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Effects of Periodontal Treatment on HIV-infected Patients

Primary Purpose

HIV/AIDS, Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Basic periodontal treatment
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring Chronic periodontitis, Candida spp, Histatin-5, Lactoferrin

Eligibility Criteria

36 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • General for both groups/arms: Patients with at least 15 teeth; with chronic periodontitis (at least 2 sites with pocket probing depth ≥ 5mm and clinical attachment loss >4mm); no use of antibiotics for the 6 months previous to study enrolment.
  • For HIV-infected group: CD4 T lymphocytes < 200 cel/mm3, stable HAART for the 6 months previous to study enrollment.

Exclusion Criteria:

  • General for both groups/arms: periodontal treatment and use of antibiotics for the 6 months previous to study enrollment; smoking; complex systemic conditions.

Sites / Locations

  • School of Dentistry of Ribeirão Preto, University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIV-infected group

Non-HIV infected group

Arm Description

Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.

Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.

Outcomes

Primary Outcome Measures

Change in clinical signs of chronic periodontitis.
Clinical parameters of the periodontal diseases: Dental biofilm index and bleeding on probing (BOP) measured in percentage associated to pocket probing depth (PPD) and clinical attachment loss (CAL) measured in millimeters will be combined to report the effect of periodontal treatment on the chronic periodontitis in percentage of sites with no periodontal diseases signs.

Secondary Outcome Measures

Change in Candida spp carriage.
Number of Candida spp colonies on culture plates.
Change in salivary biomarkers
Concentrations of histatin, lactoferrin and inflammatory cytokines in saliva and gingival crevicular fluid in pg/mL.
Change in bacterial microbiota
Pyrosequencing characterization of the bacterial microbiota

Full Information

First Posted
August 19, 2017
Last Updated
March 25, 2020
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03262402
Brief Title
Effects of Periodontal Treatment on HIV-infected Patients
Official Title
Determination of Factors Involved in the Pathogenesis of Periodontal Diseases in HIV-infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 2, 2017 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
April 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Periodontal diseases, such as chronic periodontitis (CP), frequently occur in immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by the HIV infection can justify the high frequency and the difficult in controlling the CP in this group of patients, raising the possibility of additional factors associated to the development of CP in HIV patients. The aim of this study is to determine factors that can be involved in the CP pathogenesis in HIV patients, including Candida spp presence, and biomarkers involved on the inflammatory response against the microorganisms.
Detailed Description
Investigators will develop one quasi-experimental study in HIV patients (N=15) and non-HIV patients (N=15) presenting CP. Candida spp count and salivary and gingival crevicular fluid concentrations of histatin, lactoferrin, interleukin-1β, interleukin-6, and tumor necrosis factor-α will be determined at baseline, 30 and 90 days after the periodontal treatment. In order to minimize the influence of the immunosuppressive condition, patients have to present CD4 T lymphocytes < 200cel/mm3 blood count, non-detectable viral load and the same protocol of antiretroviral therapy. Additionally, investigators intend to determine the immunophenotypic profile of the gingival tissue through immunohistochemical analysis. This study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto (CAAE: 50004415.1.0000.5419), and all patients need to provide written informed consent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Periodontal Diseases
Keywords
Chronic periodontitis, Candida spp, Histatin-5, Lactoferrin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV-infected group
Arm Type
Experimental
Arm Description
Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.
Arm Title
Non-HIV infected group
Arm Type
Active Comparator
Arm Description
Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.
Intervention Type
Procedure
Intervention Name(s)
Basic periodontal treatment
Other Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.
Primary Outcome Measure Information:
Title
Change in clinical signs of chronic periodontitis.
Description
Clinical parameters of the periodontal diseases: Dental biofilm index and bleeding on probing (BOP) measured in percentage associated to pocket probing depth (PPD) and clinical attachment loss (CAL) measured in millimeters will be combined to report the effect of periodontal treatment on the chronic periodontitis in percentage of sites with no periodontal diseases signs.
Time Frame
Baseline, 30 days and 90 days.
Secondary Outcome Measure Information:
Title
Change in Candida spp carriage.
Description
Number of Candida spp colonies on culture plates.
Time Frame
Baseline, 30 days and 90 days.
Title
Change in salivary biomarkers
Description
Concentrations of histatin, lactoferrin and inflammatory cytokines in saliva and gingival crevicular fluid in pg/mL.
Time Frame
Baseline, 30 days and 90 days.
Title
Change in bacterial microbiota
Description
Pyrosequencing characterization of the bacterial microbiota
Time Frame
Baseline, 30 days and 90 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: General for both groups/arms: Patients with at least 15 teeth; with chronic periodontitis (at least 2 sites with pocket probing depth ≥ 5mm and clinical attachment loss >4mm); no use of antibiotics for the 6 months previous to study enrolment. For HIV-infected group: CD4 T lymphocytes < 200 cel/mm3, stable HAART for the 6 months previous to study enrollment. Exclusion Criteria: General for both groups/arms: periodontal treatment and use of antibiotics for the 6 months previous to study enrollment; smoking; complex systemic conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Carolina F Motta, DDS, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry of Ribeirão Preto, University of São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040-904
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data of all primary and secondary outcomes will be made available.
IPD Sharing Time Frame
Data will be available within 3 months of study completion.
IPD Sharing Access Criteria
Data access criteria will be reviewed by the an external independent review panel.
Citations:
PubMed Identifier
28591257
Citation
Lourenco AG, Ribeiro AERA, Nakao C, Motta ACF, Antonio LGL, Machado AA, Komesu MC. Oral Candida spp carriage and periodontal diseases in HIV-infected patients in Ribeirao Preto, Brazil. Rev Inst Med Trop Sao Paulo. 2017 Jun 1;59:e29. doi: 10.1590/S1678-9946201759029.
Results Reference
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PubMed Identifier
24720483
Citation
Lourenco AG, Rodrigues Alves Ribeiro AE, Nakao C, Fragoso Motta AC, Machado AA, Komesu MC. Influence of antiretroviral therapy and periodontal disease on human salivary beta-defensin 2 in patients infected with HIV. Curr HIV Res. 2014;12(1):44-9. doi: 10.2174/1570162x12666140407125120.
Results Reference
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Effects of Periodontal Treatment on HIV-infected Patients

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